Immunoglobulin G (Igg) Infusion System

FDA product code PKP · Class II (moderate risk) · 21 CFR 880.5725 · General Hospital

An Immunoglobulin G (IgG) Infusion System is a prescription device intended for subcutaneous delivery of Immunoglobulin G (IgG) in accordance with the FDA approved labeling.

7510(k) clearances
0PMA approvals
0recalls

Manufacturers

510(k) clearances

510(k)DeviceApplicantDecision
K251105Tetra (TM-20); Tetra (TM-50)PKP · Traditional Emed Technologies Corporation12/22/2025SE
K240148SCIg60 Infusion SystemPKP · Special Emed Technologies Corporation02/16/2024SE
K230883VersaPump Infusion SystemPKP · Traditional Emed Technologies Corporation11/28/2023SE
K222087SCIg60 Infusion SystemPKP · Traditional Emed Technologies Corporation10/13/2022SE
K173783SCIg60 Infusion SystemPKP · Traditional Emed Technologies Corporation12/14/2018SE
K161906SCIg60 InfuserPKP · Traditional Emed Technologies Corporation12/01/2016SE
K142319SCIg60 Infuser, InfusetPKP · Traditional Emed Technologies Corporation05/14/2015SE